Important deal highlights:
- Estelle® is a novel combined oral contraceptive (COC) product candidate developed by Mithra Women's Health (Mithra)
- Estelle® is composed of 15mg Estetrol (E4), its unique native estrogen, and 3mg drospirenone (DRSP)
- Pivotal phase III trials (E4 Freedom) are ongoing in Europe and Russia as well as in the US and Canada, with top line results expected in Q3 2018 and Q1 2019, respectively
- With Estelle®, Searchlight Pharma further expands its industry-leading footprint in Women's Health in Canada
MONTREAL, May 30, 2018 /CNW Telbec/ - Searchlight Pharma, a Canadian specialty pharmaceutical company committed to improving life-long human health and wellness, today announced the signing of an exclusive licensing agreement to commercialize Estelle® in Canada. Estelle® is Mithra's novel combined oral contraceptive (COC) product candidate currently in pivotal Phase III trials in Europe and Russia as well as in the US and Canada, with top line results expected in Q3 2018 and Q1 2019, respectively. This agreement formally concludes business discussions that had been underway between the parties since the announcement by Mithra of a Heads of Terms agreement on April 12, 2018. Further details and terms of the definitive agreement were not disclosed.
According to December 2017 IQVIA CDH data, the Canadian contraceptive market was valued in excess of $230 million. The only COC products containing the same progestin as Estelle®, namely Yasmin® and Yaz®, achieved peak annual sales of approximately $35 million and $20 million respectively. A total of seven products in the Canadian contraceptive category recorded sales of at least $10 million in 2017. All of these market statistics suggest the potential commercial promise in Canada of an innovative product candidate like Estelle®.
"Estelle® represents the first significant innovation in the COC category in well over a decade. The potential contraceptive efficacy and safety benefits to Canadian women, together with the anticipated improved user acceptance on the basis of the clinical results announced to date, suggest that Estelle® holds the potential to become a leading product in the Canadian contraception market. We are proud that Mithra recognized Searchlight's industry-leading Women's Health expertise and commercial capabilities and track record by selecting us as the partner of choice to bring this important innovation to market in Canada," said Mark Nawacki, President & CEO of Searchlight Pharma.
"We are very pleased to have concluded this agreement with Searchlight Pharma for the commercialization of Estelle® in Canada," said François Fornieri, CEO of Mithra. "Given their focus, we are convinced that as a leading and rapidly growing Canadian Women's Health specialist, Searchlight Pharma is the best possible partner for the commercialization of Estelle® in Canada. In addition, we also remain very pleased with the progress of the ongoing Phase III program as has been highlighted in several recent announcements. We look forward to reporting top-line results in Q3 2018 for Europe/Russia and in Q1 2019 for US/Canada, and we continue to believe that Estelle® has the potential to become a true 'next generation' contraceptive, offering a beneficial risk/benefit profile to women in Canada and worldwide."
Estelle® is Mithra's novel oral contraceptive product candidate composed of 15 mg Estetrol (E4), its unique native estrogen, and 3 mg DRSP. Currently, pivotal Phase III Estelle® trials (E4 Freedom) are ongoing in Europe and Russia as well as in the US and Canada, with top line results expected in Q3 2018 and Q1 2019, respectively.
About the E4 Freedom Estelle® Phase III program
The E4 Freedom Phase III program consists of two open-label, single arm studies. The European/Russian Phase III Estelle® study has enrolled 1,577 subjects aged 18-50 years of whom 1,350 subjects are aged 18-35 years. The study is taking place in 69 centres across Europe and Russia. The Phase III Estelle® study design in the US & Canada has enrolled 2,148 subjects aged 16-50 years of whom 1,940 subjects are aged 16-35 years. The study is taking place in approximately 77 centres across the US and Canada. Estelle® is Mithra's combined oral contraceptive (COC) candidate composed of 15 mg Estetrol (E4) and 3 mg drospirenone (DRSP).
The objectives of both studies are to evaluate the contraceptive's efficacy, cycle control, and the general safety and acceptability of the 15 mg E4 (Estetrol) and 3 mg DRSP combination oral contraceptive pill in healthy women, and involves subject participation for a period of minimum 12 months (13 cycles, 1 cycle = 28 days).
The primary outcome is contraceptive efficacy measured by the number of pregnancies per 100 women per 12 months of exposure (Pearl Index; PI) in the primary population. In Europe/Russia this is in subjects aged 18-35 years old and in the US/Canada in subjects aged 16 to 35 years old.
Secondary outcomes include the method failure PI in the primary population as well as the PI within the overall study population. Also, cycle control and bleeding profile, safety and tolerability, and general wellbeing of the subjects (measured by two questionnaires) are analyzed. A pharmacokinetic (PK) substudy, in the US/Canada study, will assess the effect of various individual characteristics/covariates (such as race and BMI) on the PKs of 15 mg E4/3 mg DRSP.
About Searchlight Pharma Inc.
Searchlight Pharma Inc., headquartered in Montreal, aspires to become a leading Canadian-based specialty healthcare company through best-in class execution of the search, acquisition, commercialization, and focused development of innovative and unique specialty healthcare products that improve life-long human health and wellness. With a core focus on women's health, urology, and pediatrics, our team is committed to improving people's lives by bringing the right products to market. Follow us, learn more about what we do, and get to know our product portfolio at www.searchlightpharma.com.
Mithra (Euronext: MITRA) is dedicated to providing innovation and choice in women's health, with a particular focus on fertility, contraception and menopause. Mithra's goal is to develop new and improved products that meet women's needs for better safety and convenience. Its two lead development candidates - a fifth generation oral contraceptive, Estelle®, and a next generation hormone therapy, Donesta®- are built on Mithra's unique natural estrogen platform, E4 (Estetrol). Mithra also develops, manufactures and markets complex therapeutics and offers partners a complete spectrum of research, development and specialist manufacturing at its Mithra CDMO. Mithra was founded in 1999 as a spin-off of the University of Liège by Mr. François Fornieri and Prof. Dr. Jean-Michel Foidart and is headquartered in Liège, Belgium. Further information can be found at: www.mithra.com.
Estelle® is a registered trademark of Estetra and is under license from Mithra Pharmaceuticals SA. Yasmin® and Yaz® are registered trademarks owned by Bayer Intellectual Property GmbH.
SOURCE Searchlight Pharma Inc.
For further information: for media representatives only: Mark Nawacki, CPA, CA, President & CEO Searchlight Pharma Inc., Phone: 514-613-1513, [email protected]; Sofie Van Gijsel, IRO, +32 485 19 14 15, [email protected], [email protected]